Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit at King Abdullah Specialist Children Hospital- Ministry of National Guard Health Affairs.

Prospective, Randomized, Open Label Controlled Trial To Evaluate The Safety And Efficacy Of Dexmedetomidine Use Beyond 24 Hours Compared With Midazolam In Children Admitted To Pediatric Intensive Care Unit (PICU) at KASCH-MNGHA.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05485519

Acronym

PROMISE

Enrollment

430

Registered

2022-08-03

Start date

2022-04-21

Completion date

2024-05-31

Last updated

2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmedetomidine, Failure of Extubation, Midazolam, Withdrawal Symptoms

Keywords

Dexmedetomidine, Midazolam, Intubation, Withdrawal Symptoms, failure of Extubating

Brief summary

Study will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. Total of 430 patients will participate to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours in pediatric Intensive Care Unite.

Detailed description

Prospective, randomized, open label, controlled study, will be conducted in Pediatric Intensive Care Unit (PICU) in King Abdullah Specialist Children Hospital (KASCH), National Guard Health Affairs, Riyadh, Saudi Arabia. 340 patients will be randomly randomized to Midazolam (M) or Dexmedetomidine (D), to assess the safety and efficacy of prolonged Dexmedetomidine use beyond 24 hours.

Interventions

DRUGDexmedetomidine

Infusion start at 0.5 mcg/kg/hour. Titrate to effect (up to1.5 mcg/kg/hour)

DRUGMidazolam

(1 mcg/kg/minute. up to a maximum of 5 mcg/kg/minute.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 14 Years

Healthy volunteers

Inclusion criteria

1. Age 1-14 years both male and female who require mechanical ventilation 2. Informed consent from signed by patient's legal representatives, and for patients aged 12- 14 who has an age-appropriate understanding additional assent form signed by patient is required. 3. Intubated within 6 hours and anticipated to require mechanical ventilation for more than 48 hours

Exclusion criteria

1. Septic shock and/or multi-organ failure. 2. Hemodynamically instability and requires inotropes. 3. Severe intracranial or spinal trauma with high intracranial pressure 4. Liver failure 5. Acute or chronic renal failure. 6. Glasgow Coma Scale (GCS) ≤8 7. Known to have allergy to the study drugs 8. Airway surgery

Design outcomes

Primary

Measure	Time frame
Mean time taken from end of sedation to extubation with no or minimal withdrawal symptoms	from end of sedation to extubation assessed up to 24 hrs

Secondary

Measure	Time frame
To compare length of PICU stay in both groups	from Intubation to discharge assessed up to 1 month

Countries

Saudi Arabia

Contacts

Primary ContactMajed A Jeraisy

jjeraisym@ngha.med.sa+966-504192291

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026